CER BIOLOXD OPTION HD 36MM
Report
- Report Number
- 0001825034-2019-03830
- Event Type
- Injury
- Date Received
- August 28, 2019
- Report Date
- December 18, 2019
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LZO
- PMA / PMN Number
- K082996
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 110010267 G7 OSSEOTI MULTIHOLE 58MM G LOT#: 3899651, CATALOG#: 650-1064 CER OPTION TYPE 1 TPR SLEVE -6 LOT#: 2912211, CATALOG#: 010000937 G7 HI-WALL E1 LINER 36MM G LOT#: 3814614, CATALOG#: 010000998 G7 SCREW 6.5MM X 25MM LOT#: 6091325, CATALOG#: 010000998 G7 SCREW 6.5MM X 25MM LOT#: 3727750, CATALOG#: 010000997 G7 SCREW 6.5MM X 20MM LOT#: 6062820, CATALOG#: 010000994 G7 APICAL HOLE PLUG LOT#: 3676795.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO LOCATION OF DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03827, 0001825034-2019-03828, 0001825034-2019-03829.
IT WAS REPORTED PATIENT IS EXPERIENCING PAIN POST ¿IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734122 | CER BIOLOXD OPTION HD 36MM | PROSTHESIS, HIP | LZO | ZIMMER BIOMET, INC. | N/A | 2897734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | UNKNOWN CUP| UNKNOWN LINER| UNKNOWN STEM| UNKNOWN CUP| UNKNOWN LINER| UNKNOWN STEM |